Methods and apparatuses for transdermal electrical stimulation

Abstract

Methods and apparatuses for transdermal electrical stimulation. Described herein are single-use or limited-use TES apparatuses and methods of using them that include an integrated (e.g., flex-circuit) electrode assembly and controller apparatus including a waveform generator and power supply. Also described herein are TES apparatuses including a cord or wire having current control circuitry and configured to connect a mobile computing device (e.g., smartphone or wearable electronics) to an electrode assembly. Finally, also described herein are intermediate apparatuses including a flex-circuit electrode assembly including a waveform generator but receiving power from a cable connected to a mobile computing device.

What is claimed is: 
     
       1. A neuromodulation apparatus for delivering transdermal electrical stimulation (TES) to a wearer, the apparatus comprising:
 a flat and flexible substrate having a first end, wherein the first end comprises a first end top surface and a first end bottom surface, and a second end, wherein the second end comprises a second end top surface and a second end bottom surface; 
 a first electrode portion at the first end, a first electrode active region disposed on the first end bottom surface; 
 a second electrode portion comprising a second electrode active region disposed on the second end, wherein the first electrode active region and the second electrode active region are configured to deliver energy to the wearer's skin; 
 a flexible elongated substrate region separating the first end and the second end by a path length of at least two inches, the flexible elongated substrate region configured to take on a flat configuration that defines a plane, wherein the flexible elongated substrate region is flexible out of the plane and rigid in the plane, wherein the flexible elongated substrate region includes a bend within the plane; and 
 an assembly of neuromodulation components integrated onto the first end, or the second end, or the flexible elongated substrate region, or a combination thereof, configured to control the first electrode portion and the second electrode portion to deliver at least one pre-programmed TES waveform to the wearer's skin at the first electrode active region and at the second electrode active region, the assembly including a near-field communication circuit and a near-field communication selector adhered to or near the near-field communication circuit, wherein the near-field communication selector encodes one or more ensemble waveforms for delivery to the wearer. 
 
     
     
       2. The apparatus of  claim 1 , wherein the assembly of neuromodulation components comprises a waveform generator. 
     
     
       3. The apparatus of  claim 1 , further comprising a power source. 
     
     
       4. The apparatus of  claim 1 , further comprising at least one of: a controller, a memory, a skin-impedance sensing circuit, and a timer. 
     
     
       5. The apparatus of  claim 1 , further comprising an adhesive on the first end bottom surface for securing the apparatus to the wearer's skin. 
     
     
       6. The apparatus of  claim 1 , wherein the first electrode portion is configured to fit against a temple region of the wearer. 
     
     
       7. The apparatus of  claim 1 , wherein the first electrode active region extends from a first edge of the first electrode portion, across a lower surface of the first electrode portion, to a second edge of the first electrode portion. 
     
     
       8. The apparatus of  claim 1 , wherein the flexible elongated substrate region comprises a wire. 
     
     
       9. The apparatus of  claim 1 , wherein the flexible elongated substrate region comprises a planar region that is flexible in a first direction but not flexible in a direction normal to the first direction. 
     
     
       10. The apparatus of  claim 1 , wherein the assembly of neuromodulation components comprises surface mounted components, custom application specific integrated circuits, micro-electronic mechanical devices, or a combination thereof. 
     
     
       11. The apparatus of  claim 1 , further comprising at least one of: an on/off switch, a control for selecting a waveform, and a display for showing the wearer a particular waveform selected. 
     
     
       12. The apparatus of  claim 1 , further comprising a cord configured to connect the assembly of neuromodulation components to a handheld computing device. 
     
     
       13. The apparatus of  claim 12 , wherein the cord is configured to connect the assembly of neuromodulation components to the handheld computing device comprising a smartphone. 
     
     
       14. The apparatus of  claim 1 , wherein the flexible elongated substrate region doubles back at the bend when in the flat configuration. 
     
     
       15. The apparatus of  claim 1 , wherein the flexible elongated substrate includes an electrical path defined by the path length, wherein the electrical path doubles back at the bend when the flexible elongated substrate region is in the flat configuration. 
     
     
       16. The apparatus of  claim 1 , wherein the near-field communication selector includes a coil and circuitry encoding control information for the one or more ensemble waveforms. 
     
     
       17. The apparatus of  claim 1 , wherein the one or more ensemble waveforms includes sequences of different component waveforms having one or more: different peak current amplitudes, different frequencies, different percent duty cycles, different percent charge imbalances, different capacitive discharge periods, different bursting frequency, and different bursting duty cycles. 
     
     
       18. The apparatus of  claim 1 , wherein the one or more ensemble waveforms includes added, subtracted, convolved, or amplitude modulated waveforms. 
     
     
       19. The apparatus of  claim 1 , wherein the one or more ensemble waveforms includes segments with different pulsing parameters. 
     
     
       20. The apparatus of  claim 1 , wherein the near-field communication selector is a sticker or stamp. 
     
     
       21. A system for delivering transdermal electrical stimulation (TES) to a subject's head or head and neck, the system comprising:
 a substrate having a first end and a second end, the first end comprising a top surface and a bottom surface; 
 a first electrode portion disposed on the first end; 
 a first electrode active region disposed on the bottom surface of the first end; 
 wherein the second end comprises a top surface and a bottom surface: 
 a second electrode portion, comprising a second electrode active region, disposed on the second end; 
 wherein the first electrode active region and the second electrode active region are configured to deliver energy to the subject's skin; 
 a flexible elongated member separating the first end and the second end by a path length of at least two inches, the flexible elongated member configured to take on a flat configuration that defines a plane, wherein the flexible elongated member is flexible out of the plane and rigid in the plane, the flexible elongated member including a bend within the plane to accommodate wrapping of the flexible elongated member around at least a portion of the subject's head or head and neck; 
 a tether for connecting the substrate to a telecommunication device; and 
 an assembly of neuromodulation components integrated into the first end, the second end, the flexible elongated member, the tether, or a combination thereof, the assembly of neuromodulation components configured to control the first electrode portion and the second electrode portion to deliver at least one pre-programmed waveform stimuli to the subject's skin at the first active electrode region and at the second active electrode region, the assembly including a near-field communication circuit and a near-field communication selector adhered to or near the near-field communication circuit, wherein the near-field communication selector is configured to unlock one or more ensemble waveforms for delivery to the subject. 
 
     
     
       22. The system of  claim 21 , further comprising the telecommunication device configured to control the at least one pre-programmed waveform stimuli to be outputted by the first electrode active region and the second electrode active region. 
     
     
       23. The system of  claim 22 , wherein the telecommunication device comprises an application for controlling the at least one pre-programmed waveform stimuli to be outputted. 
     
     
       24. The system of  claim 22 , wherein the tether comprises a first end for connecting to a neuromodulation device and a second end for connecting to the telecommunication device. 
     
     
       25. The system of  claim 21 , wherein the tether is a cord or a wire. 
     
     
       26. The system of  claim 21 , wherein the tether comprises an amplifier for boosting the at least one pre-programmed waveform stimuli to be outputted. 
     
     
       27. The system of  claim 21 , wherein the tether comprises electronic circuitry for controlling the at least one pre-programmed waveform stimuli. 
     
     
       28. The system of  claim 21 , wherein the first end further comprises at least one connector for connecting to the tether. 
     
     
       29. The system of  claim 21 , wherein the second end further comprises at least one connector for connecting to the tether. 
     
     
       30. The system of  claim 21 , further comprising an adhesive on the bottom surface of the first end and an adhesive on the second electrode portion for securing the substrate to the subject's skin. 
     
     
       31. The system of  claim 21 , wherein the first electrode portion is of a shape and a size that can fit in a wearer's temple region. 
     
     
       32. The system of  claim 21 , wherein the first electrode active region extends from a first edge of the first electrode portion, across the bottom surface of the first electrode portion, to a second edge of the first electrode portion. 
     
     
       33. The system of  claim 21 , wherein the flexible elongated member comprises a wire. 
     
     
       34. The system of  claim 21 , wherein the flexible elongated member comprises a planar substrate that is flexible in a first direction but not flexible in a direction normal to the first direction. 
     
     
       35. The system of  claim 21 , wherein the assembly of neuromodulation components comprises surface mounted components, custom application specific integrated circuits, micro-electronic mechanical devices, or a combination thereof. 
     
     
       36. The system of  claim 21 , further comprising one or more of an on/off switch, a control for selecting a particular waveform, and a display for showing the subject the particular waveform selected.